Manager Quality Control (mwd)

Job Description

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities along with our external contractors suppliers and partners create a reliable global manufacturing network that is devoted to delivering a high-quality reliable supply to customers and patients on time every time.

Our site in 1210 Vienna is a strategic location for solid drug manufacturing including tablets coated tablets granules and implants for the health provision and treatment of livestock and domestic animals. Most of our products are exported. To ensure sustainable company growth we continually strive to offer attractive career opportunities for more than 450 employees at our Vienna support of our existing team we are currently looking for a:

Manager Quality Control (m/w/d)

full-time; 2-year fixed-term contract

The QC Manager QC Systems and Equipment is responsible for the governance lifecycle management qualification and compliance of Quality Control computerized systems and QC equipment with a strong focus on LIMS Empower QCrelevant GxP system and equipment qualification and data integrity.

The role manages a team of QC Systems / QC Specialists and ensures that QC systems and equipment are fit for intended use fully qualified and inspectionready at all times in alignment with cGMP data integrity requirements and company quality standards.
The position acts as System Owner and Equipment Owner (or SubSystem Owner) and serves as a key interface to QC laboratories QA IT CSV Engineering Global functions and Regulatory Affairs.

The role supports nonroutine projects and compliance topics (e.g. Deviations CAPAs Change Controls OOS/OOT Audits Regulatory Requests) related to QC systems electronic data and QC equipment.

Responsibilities

• Overall responsibility for QC systems and QC equipment including LIMS Empower and laboratory instrumentation ensuring a validated and inspectionready state

• System Owner / SubSystem Owner for QC computerized systems including lifecycle management change control user management and data integrity oversight

• Responsibility for qualification and requalification of QC equipment (IQ/OQ/PQ) including oversight of vendors documentation and periodic reviews

• Leads and supports QC system and equipmentrelated compliance activities (Deviations CAPAs Change Controls OOS/OOT audits regulatory requests)

• Drives continuous improvement of QC systems digital processes and equipment reliability in close collaboration with QC QA IT CSV and Engineering

• Manages coaches and develops a team of QC Systems / QC Specialists ensuring adequate training resourcing and succession planning

• Ensures adherence to cGMP data integrity quality systems and EHS requirements and actively supports inspections and selfinspections

Qualifications Experience & Skills

• University degree in chemistry or natural sciences

• Strong expertise in QC computerized systems and laboratory environments including LIMS Empower and systemsupported analytical workflows

• Solid background in qualification and lifecycle management of QC equipment and GxP systems (IQ/OQ/PQ periodic review change control)

• Proven understanding of cGMP and data integrity requirements with the ability to apply them pragmatically in daily operations

• People leadership and coaching skills with experience developing technical specialists and building engaged highperforming teams

• Ability to lead and manage compliance topics such as deviations CAPAs audits and inspections in a structured and confident manner

• Strong crossfunctional collaboration skills working effectively with QC labs QA IT Engineering and global stakeholders

• Structured proactive and improvementoriented mindset with the ability to drive continuous improvement and digitalization initiatives

We offer

• Exciting and varied field of work in a modern internationally operating company

• Annual bonus and employee recognition bonuses

• Employee referral program

• Attractive company pension

• Paid parental leave up to 12 weeks provided by company

• Company medical care and vaccination program

• Discounted fitness offer

• Fruit coffee & tea

• Modern company canteen with generous company subsidy

• Annual ticket for Wiener Linien or subsidy for climate ticket and/or bike leasing

• Various employee discounts and benefits and much more!

We offer an attractive salary outstanding social benefits and an exciting work environment with varied tasks in an international environment. The minimum annual salary for this position is EUR 61.300 and varies according to the qualifications and experience of the successful candidate. We are looking forward to receiving your application.

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.

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